Devices from naturally occurring biologically derived materials

ABSTRACT

Orthopaedic devices are disclosed. The devices include a part that is made of extracellular matrix material that has been hardened. One method of hardening the extracellular matrix is to comminute naturally occurring extracellular matrix and dry the comminuted material. The hardened extracellular matrix material can be machined to form a variety of orthopaedic devices.

CROSS REFERENCE

[0001] This application claims priority to U.S. Patent Application No.60/389,028, filed Jun. 14, 2002, and U.S. Provisional Application No.60/305,786, filed Jul. 16, 2001, hereby incorporated by reference.

[0002] Cross reference is made to copending U.S. patent applicationsSerial No. ______ entitled “Meniscus Regeneration Device and Method”(Attorney Docket No. 265280-71141, DEP-745); Serial No. ______ entitled“Cartilage Repair Apparatus and Method” (Attorney Docket No.265280-71143, DEP-749); Serial No. ______ entitled “Unitary SurgicalDevice and Method” (Attorney Docket No. DEP-750); Serial No. ______entitled “Hybrid Biologic/Synthetic Porous Extracellular MatrixScaffolds” (Attorney Docket No. 265280-71144, DEP-751); Serial No.______ entitled “Cartilage Repair and Regeneration Device and Method”(Attorney Docket No. 265280-71145, DEP-752); Serial No. ______ entitled“Porous Extracellular Matrix Scaffold and Method” (Attorney Docket No.265280-71146, DEP-747); Serial No. ______ entitled “Cartilage Repair andRegeneration Scaffolds and Method” (Attorney Docket No. 265280-71180,DEP-763); and Serial No. ______ entitled “Porous Delivery Scaffold andMethod” (Attorney Docket No. 265280-71207, DEP-762), each of which isassigned to the same assignee as the present application, each of whichis filed concurrently herewith, and each of which is hereby incorporatedby reference. Cross reference is also made to U.S. patent applicationSer. No. 10/172,347 entitled “Hybrid Biologic-Synthetic BioabsorbableScaffolds” which was filed on Jun. 14, 2002, which is assigned to thesame assignee as the present application, and which is herebyincorporated by reference.

BACKGROUND AND SUMMARY OF THE INVENTION

[0003] The present invention relates to devices for attaching, repairingor regenerating orthopedic tissue, particularly to such devices madefrom naturally occurring extracellular matrix cured or treated to havestructural rigidity and hardness.

[0004] It is known to use various collagen scaffolds to provide ascaffold for repair and regeneration of damaged tissue. U.S. Pat. No.6,042,610 to ReGen Biologics, hereby incorporated by reference,discloses the use of a device comprising a bioabsorbable material madeat least in part from purified natural fibers. The purified naturalfibers are cross-linked to form the device of U.S. Pat. No. 6,042,610.The device can be used to provide augmentation for a damaged meniscus.Related patents U.S. Pat. No. 5,735,903, 5,479,033, 5,306,311,5,007,934, and 4,880,429 also disclose a meniscal augmentation devicefor establishing a scaffold adapted for ingrowth of meniscalfibrochondrocyts.

[0005] It is also known to use naturally occurring extracellularmatrices (ECMs) to provide a scaffold for tissue repair andregeneration. One such ECM is small intestine submucosa (SIS). SIS hasbeen described as a natural acellular biomaterial used to repair,support, and stabilize a wide variety of anatomical defects andtraumatic injuries. See, for example, Cook® Online New Release providedby Cook Biotech Inc. at “www.cookgroup.com”. The SIS material is derivedfrom porcine small intestinal submucosa that models the qualities of itshost when implanted in human soft tissues. Further, it is taught thatthe SIS material provides a natural scaffold-like matrix with athree-dimensional structure and biochemical composition that attractshost cells and supports tissue remodeling. SIS products, such as OASISand SURGISIS, are commercially available from Cook Biotech Inc.,Bloomington, Ind.

[0006] Another SIS product, RESTORE Orthobiologic Implant, is availablefrom DePuy Orthopaedics, Inc. in Warsaw, Ind. The DePuy product isdescribed for use during rotator cuff surgery, and is provided as aresorbable framework that allows the rotator cuff tendon to regenerate.The RESTORE Implant is derived from porcine small intestine submucosa, anaturally occurring ECM (composed of mostly collagen type I (about 90%of dry weight) glycosaminoglycans and other biological molecules), thathas been cleaned, disinfected, and sterilized. During seven years ofpreclinical testing in animals, there were no incidences of infectiontransmission from the implant to the host, and the RESTORE Implant hasnot adversely affected the systemic activity of the immune system.

[0007] While small intestine submucosa is available, other sources ofsubmucosa are known to be effective for tissue remodeling. These sourcesinclude, but are not limited to, stomach, bladder, alimentary,respiratory, or genital submucosa, or liver basement membrane. See,e.g., U.S. Pat. Nos. 6,379,710, 6,171,344, 6,099,567, and 5,554,389,hereby incorporated by reference. Further, while SIS is most oftenporcine derived, it is known that these various submucosa materials maybe derived from non-porcine sources, including bovine and ovine sources.Additionally, the ECM material may also include partial layers oflaminar muscularis mucosa, muscularis mucosa, lamina propria, stratumcompactum and/or other tissue materials depending upon factors such asthe source from which the ECM material was derived and the delaminationprocedure.

[0008] For the purposes of this invention, it is within the definitionof a naturally occurring ECM to clean and/or comminute the ECM, or tocross-link the collagen within the ECM. It is also within the definitionof naturally occurring extracellular matrix to fully or partially removeone or more components or subcomponents of the naturally occurringmatrix. However, it is not within the definition of a naturallyoccurring ECM to extract, separate and purify the natural components orsub-components and reform a matrix material from purified naturalcomponents or sub-components. Also, while reference is made to SIS, itis understood that other naturally occurring ECMs (e.g. stomach,bladder, alimentary, respiratory or genital submucosa, and liverbasement membrane), whatever the source (e.g. bovine, porcine, ovine)are within the scope of this invention. Thus, in this application, theterms “naturally occurring extracellular matrix” or “naturally occurringECM” are intended to refer to extracellular matrix material that hasbeen cleaned, disinfected, sterilized, and optionally cross-linked.

[0009] The following U.S. patents, hereby incorporated by reference,disclose the use of ECMs for the regeneration and repair of varioustissues: U.S. Pat. Nos. 6,379,710; 6,187,039; 6,176,880; 6,126,686;6,099,567; 6,096,347; 5,997,575; 5,993,844; 5,968,096; 5,955,110;5,922,028; 5,885,619; 5,788,625; 5,762,966; 5,755,791; 5,753,267;5,733,337; 5,711,969; 5,645,860; 5,641,518; 5,554,389; 5,516,533;5,445,833; 5,372,821; 5,352,463; 5,281,422; and 5,275,826. U.S. Pat. No.5,352,463 discloses an SIS pillow filled with comminuted SIS forregeneration of a meniscus. While U.S. Pat. No. 5,352,463 contemplatesthe general concept of meniscus regeneration with an SIS filled pouch,it does not address itself to providing such a pouch having thecapability of withstanding the compression and shear stresses involvedin an implant for regenerating a meniscus. Also, U.S. Pat. No. 5,352,463does not contemplate placing structural members formed from naturallyoccurring ECM, where in the ECM is right and hardened.

[0010] It is known to use materials such as catgut and SIS to makeappliances. See WO 95/06439 to Bolesky. The Bolesky applicationdiscloses devices that are semi-rigid and are formed into desiredshapes, but Bolesky does not disclose a process for fabricatingnaturally occurring extracellular matrix parts that are rigid andhardened.

[0011] In the present invention, the density and porosity of theextracellular matrix material can be controlled with drying protocols,including air drying, air drying with heat, and air drying withpressure. Thus, the ECM material can be dried to have a hardnesssufficient to machine the device, without the need to form the deviceinto the general shape by molding. By managing density and porosity ofthe ECM, various fixation devices can be made having superior materialproperties, wherein the devices promote healing while remainingbiocompatable and biodegradable.

[0012] The present invention, in one of its embodiments, is anorthopedic device for attaching soft tissue such as cartilage,ligaments, and tendons to bone. The device, which in one embodiment hasa head end portion configured to engage soft tissue and a body portionconfigured to engage and attach to the bone, is preferably monolithicand formed as a unitary structure from naturally occurring extracellularmatrix. The body portion of the device may illustratively terminate witha pointed end distal from the head portion to facilitate the penetrationinto the bone. Between the pointed distal end and the head portion, thedevice may illustratively be formed with radially outwardly extendingbarbs. These barbs may incline toward the head portion to provide abarbed tack or tack-like device. In some embodiments, a body portion isprovided with diametrically opposed flats extending therealong, theflats being generally parallel.

[0013] It has been found that a mass of naturally occurring ECM may becured to be very rigid and hardened so that it can be machined usingconventional cutting tools and using laser machining. The devices ofthis invention may be formed by machining a mass of cured matrix todefine the head portion and body portion. The mass may be formed bycompressing the ECM into a solid mass. For example, the ECM may becomminuted and formed into a solid mass with interlocking strands ofECM.

[0014] For example, a tightly balled or compacted mass of pieces of SIS,illustratively comminuted SIS, can be formed by air drying or by hot airdrying to become extremely hard. Unexpectedly, this hardened SIS can bemachined or formed to have very sharp pointed ends, sharp barbs, etc.With this process, tacks, barbed tacks, and threaded elements may bemachined from such cured mass of SIS. The tacks may be double-endedtacks or may include a central head portion and a sharpened body portionextending axially from each end of the head portion. Alternatively, adevice may be made such that one body portion may be threaded whileanother body portion has barbs.

[0015] In one embodiment, such tacks or barbs may be attached to devicesmade of naturally occurring extracellular matrix laminated together toform a body portion. For example, such a body portion may be fabricatedto be placed into the tear of a meniscus to extend along the tear. Oneor more tacks or barbs made in accordance with the present invention maybe coupled to the body portion to secure the device in the tear. Each ofthese tacks may be made from naturally occurring extracellular matrixcured to be hard and rigid.

[0016] A staple or a staple-like device may be fabricated in accordancewith the present invention utilizing two or more spaced apart barbs,each having a sharpened distal end and a proximal end. A connectingmember may be placed between the proximal ends of the barbs. Thisconnecting member may itself be made from a material such as SIS andoptionally may be formed integrally with the barbs. Thus, in accordancewith the present invention, an orthopedic staple device may be made fromnaturally occurring extracellular matrix hardened to have two or moresharpened barbs connected by strands of extracellular matrix such asSIS. In some embodiments of the present invention, such a staple orstaple-like device may be made by laminating several layers of naturallyoccurring extracellular matrix and curing the layers to form a rigid andhardened sheet-like body. The barbs and the connecting member or membersare then cut from the body. It has been found that the barbs andconnecting member may be cut by laser machining a pattern on thesheet-like body. It has also been found that such barbs may be formed tohave edges fused together by the laser machining process.

[0017] In another embodiment, a device for anchoring a bone plug in anopening formed in a bone is provided. The device comprises a mass ofnaturally occurring extracellular matrix formed into a rigid andhardened member configured to be wedged in the opening between the boneplug and the bone. This rigid and hardened member may be formed withoutwardly extending barbs to dig into the bone plug and the bone. Thedevice may also have a connecting portion to extend into an opening inthe bone plug. In some embodiments, the member is designed to extendaxially along side the bone plug, and the member may have a plurality ofradially outwardly and longitudinally extending fins to dig into thebone plug and the bone. The elongated member may be cannulated so thatit may be guided into place on a guide member such as a K-wire. In someembodiments, the member may be formed in the shape of a screw to bethreaded into the opening between the bone plug and the bone.

[0018] There is provided, therefore, a method for anchoring a bone pluginto an opening formed in a bone for receiving a plug, the methodcomprising the steps of providing a member formed into a rigid andhardened mass of naturally occurring extracellular matrix and placingthe member into the opening between the bone and the bone plug. In someembodiments, the bone opening will be formed with a cylindrical wall anda bottom (or upper end) to receive a cylindrical bone plug, and theplacing step will comprise placing the member in the bone plug to engagethe bone plug and the bone. The member may be a double-ended tack, oneend of which extends into the bottom of the opening and the other end ofwhich extends into the bone plug. The double ended tack may radiallyexpand the plug to engage the wall of the opening.

[0019] In another embodiment, a device for attaching a soft tissue suchas a tendon, ligament, or ligament replacement has been provided. Thedevice, which is formed from a hardened mass of naturally occurringextracellular matrix, is provided with an elongated body to be receivedin the opening in the bone. The body has a channel therein for receivinga portion of the soft tissue. This body is configured to collapseinwardly to grip and hold the soft tissue in the channel when the bodyis inserted into the opening. In some embodiments, the body may bethreaded to accomplish inserting the device into the opening. It will beappreciated that such a device may be used for attaching an ACLreplacement ligament in a tunnel formed in a femur, wherein the tunnelhas an axis and a generally cylindrical wall. Such tunnel formation isknown in the ACL replacement art. The body may be provided with agenerally axial channel for receiving a portion of the ligamentreplacement to be attached to the femur, and the body may be formed tocollapse inwardly to secure the replacement ligament portion in thechannel as the device is threaded in the femur tunnel.

[0020] It will be appreciated that, in some embodiments, the naturallyoccurring extracellular matrix may be cured in such a fashion that thedevice will provide support structure members for various applicationsin the orthopedic field. For example, a device for regenerating ameniscus or a portion thereof may be provided with upper and lowerpanels and a support structure disposed between the upper and lowerpanels. This support structure may be provided by one or more members ofrigid and hardened naturally occurring extracellular matrix. The one ormore members may comprise a plurality of generally wedge-shaped members,each member having an upper edge supporting the upper panel and a loweredge supported on the lower panel. In other embodiments, the one or moresupport members may comprise a lattice of interlocking members, some ofwhich extend radially toward the center of the knee and others of whichextend transversely to the radially extending members. These membersarranged in the lattice structure define a plurality of spaces betweenthe upper and lower panel. These spaces may be filled with a biologicalmaterial to promote regeneration of the meniscus. For example, thespaces may be filled with comminuted SIS, a bioactive agent, abiologically-derived agent, cells, a biological lubricant, abiocompatible polymer, a biocompatible inorganic material, orcombinations thereof. The ECM support structure is believed to provide aframework for meniscus generation. The insertion of the device into aspace from which the defective portion of the meniscus has been removedand the attachment of the device to the surrounding tissue places thedevice such that the meniscus will be regenerated in the space fromwhich the defective portion has been removed. The structural membersprovided by the rigid and hardened ECM will provide the required supportfor the joint while regeneration occurs. See U.S. Provisional PatentApplication No. 60/305,786, and U.S. Patent Application Serial No.______ entitled “Meniscus Regeneration Device and Method” (AttorneyDocket No. 265280-71141, DEP-745), filed concurrently herewith, eachhereby incorporated by reference.

[0021] Thus, one aspect of this disclosure is an orthopedic device forattaching soft tissue such as cartilage, ligament and tendons to bone,the device having a head portion configured to engage soft tissue and abody portion configured to engage and attach to the bone, the headportion and body portion being monolithic and formed from naturallyoccurring extracellular matrix (ECM) cured to be rigid and hardened tofacilitate attachment to the bone.

[0022] Another aspect of this disclosure is an orthopedic tackcomprising a head portion and a first body portion formed from naturallyoccurring extracellular matrix cured to be hard and rigid.

[0023] Yet another aspect of this disclosure is a device for repairing atear in a cartilaginous surface such as a meniscus, the devicecomprising strips of naturally occurring extracellular matrix laminatedtogether to form a body portion to be placed down into the tear toextend along the tear, and one or more tacks coupled to the body portionto secure it in the tear, each of the one or more tacks being formedfrom naturally occurring extracellular matrix.

[0024] Still another aspect of this disclosure is an orthopedic devicefor attaching or repairing tissue, the device comprising two spacedapart barbs, each barb having a sharpened distal end and a proximal end,and a member connecting the proximal ends of the barbs, the barbs beingformed from naturally occurring extracellular matrix

[0025] An additional aspect of this disclosure is a device for anchoringa bone plug in an opening formed in a bone, the device comprising a massof naturally occurring extracellular matrix formed into a rigid andhardened member configured to be wedged in the opening between the boneplug and the bone.

[0026] Another additional aspect of this disclosure is a method foranchoring a bone plug into an opening formed in a bone for receiving theplug, the method comprising the steps of: providing a member formed intoa rigid and hardened mass of naturally occurring extracellular matrix,and placing the member into the opening between the bone plug and thebone.

[0027] Still another aspect of this disclosure is a device for attachinga soft tissue to a bone that has been prepared with an opening toreceive the device, the device being formed from a hardened mass ofnaturally occurring extracellular matrix to form an elongated body to bereceived in the opening, the body having a channel therein for receivinga portion of the soft tissue, the body being configured to collapseinwardly to grip and hold the soft tissue portion in the channel whenthe body is inserted into the opening.

[0028] A further aspect of this disclosure is a tack for driving into abone, the tack having a proximal head end portion, a distal pointed endportion, and an intermediate body portion, the tack being formed from ahardened mass of naturally occurring extracellular matrix.

[0029] In yet another aspect of this disclosure a device is provided forregenerating a meniscus or a portion thereof, the device comprising awedge-shaped body having an upper panel and a lower panel angularlyseparated to define an apex portion and a base portion, the panels beingformed of a naturally occurring extracellular matrix, and a supportstructure disposed between the upper panel and lower panel, the supportstructure comprising one or more members of rigid and hardened naturallyoccurring extracellular matrix.

[0030] One more aspect of this disclosure is an orthopedic devicecomprising a mass of naturally occurring extracellular matrix ornaturally occurring bioremodelable collageneous tissue matrix having ahardness greater than 30 HRD on the Rockwell D Scale.

[0031] A final aspect of this disclosure is a composite orthopedicdevice comprising two connected portions, each portion comprisingnaturally occurring extracellular matrix material or naturally occurringbioremodelable collageneous tissue matrix, each portion having ahardness and a density, wherein one portion is configured for anchoringthe device to native tissue and has a hardness of no less than 50 HRD onthe Rockwell D Scale and a density greater than 0.5 g/cc, and the otherportion has a different configuration, a different hardness and adifferent density.

IN THE DRAWINGS

[0032]FIG. 1 is a perspective view of an orthopedic device for attachingsoft tissue such as cartilage, ligaments and tendons to bone, the devicehaving a head portion configured to engage the soft tissue and a bodyportion configured to engage and attach to the bone;

[0033]FIG. 2 is a side view of the device of FIG. 1;

[0034]FIG. 3 is an end view of the device looking along the lines 3-3 inFIG. 2;

[0035]FIG. 4 is a side view of a device similar to the FIG. 1 deviceexcept that it is elongated;

[0036]FIG. 5 is a side view of the double-ended tack device;

[0037]FIG. 6 is a side view of a double-ended device, one end configuredas a tack with barbs and the other end being threaded;

[0038]FIG. 7 is an end view of the device shown in FIG. 6 looking alongthe lines 7-7;

[0039]FIG. 8 is a side view of an elongated tack-like device;

[0040]FIG. 9 is a side view of a tack-like device used to hold tissue inan opening formed in a bone;

[0041]FIG. 10 is a partially sectioned side view of a tack-like devicewith a central core filled with comminuted ECM material;

[0042]FIG. 11 is a side view of a tack-like device with a designsomewhat different from the FIG. 1 design;

[0043]FIG. 12 is an end view of the FIG. 11 device looking along thelines 12-12 in FIG. 11.

[0044]FIG. 13 is a perspective view of a device configured to collapseon soft tissue as the device is inserted into an opening in a bone;

[0045]FIG. 14 shows the device of FIG. 13 inserting soft tissue intobone.

[0046]FIG. 15 is a top view of the FIG. 16 device looking along thelines 1515 in FIG. 16.

[0047]FIG. 16 is similar to the FIG. 13 device with helical threadsegments to facilitate threading the device into an opening in a bone;

[0048]FIG. 17 is a diagrammatical drawing showing how the device of FIG.6 may be threaded into a bone plug and then how the bone plug may beinserted into the opening in a bone;

[0049]FIG. 18 is a sectional view showing the bone plug of FIG. 17installed in the bone with the double-ended device of FIG. 6;

[0050]FIG. 19 shows a double-ended tack made in accordance with thepresent invention used to insert and hold a bone plug into an opening;

[0051]FIG. 20 shows a sectional view of the bone plug of FIG. 19 afterinsertion;

[0052]FIG. 21 shows an elongated and cannulated device which has agenerally triangular cross-section with relatively sharp side edges tobe driven between a bone plug and an opening in which the plug isinserted.

[0053]FIG. 22 is a perspective view of a device similar to the FIG. 21device except that it has a generally square cross-section with fourrelatively sharp side edges;

[0054]FIG. 23 shows a perspective view of how the devices of FIGS. 21and 22 may be driven to wedge between a bone plug and a bone opening toanchor the bone plug;

[0055]FIG. 24 shows a device using barbs made in accordance with thepresent invention to hold a bone plug into an opening formed in thebone;

[0056]FIG. 25 shows an end view of the bone plug of FIG. 24 insertedinto the bone opening;

[0057]FIG. 26 shows a staple-like device made in accordance with thepresent invention.

[0058]FIG. 27 shows a variation on the staple-like device of FIG. 26;

[0059]FIG. 28 shows how a staple-like device may be cut from laminatedlayers of ECM material;

[0060]FIG. 29 shows a laminated body of ECM material held in position bytack-like devices;

[0061]FIG. 29(a) shows the device of FIG. 29 without a connecting memberbetween the tacks;

[0062]FIG. 30 shows a perspective view of staple-like devices shown inFIGS. 26 and 27 used to hold a sheet-like body of ECM material in a tearin a meniscus;

[0063]FIG. 31 shows a three-barbed staple device which may be cut fromlaminated layers of ECM material to have a desired pattern; and

[0064]FIG. 32 shows a device similar to FIG. 31, but having a differentpattern.

DETAILED DESCRIPTION OF THE DRAWINGS

[0065] FIGS. 1-3 show an orthopedic device 10 for attaching soft tissuesuch as cartilage, ligaments, tendons to bone, the device having a headportion 12 configured to engage soft tissue and a body portion 14configured to engage and attach to the bone. The head portion 12 andbody portion 14 are illustratively monolithic and formed from naturallyoccurring extracellular matrix cured to be rigid and hardened tofacilitate attachment to the bone. The body portion 14 terminates with apointed end 16 distal from the head portion 12 to facilitate penetrationinto the bone. It will be appreciated that the ECM material from whichthe device 10 is fabricated will be cured to be hardened and toughenedsuch that the device 10 may be driven into bone tissue. The pointed end16 with its hardness and toughness will facilitate insertion into thebone. To enhance the holding or gripping ability of the device 10, thebody portion 14, between the pointed end 16 and the head portion 12, isprovided with radially outwardly extending barbs or barb portions 20,22, which are illustratively inclined toward the head portion. Theseportions 20, 22 are illustratively defined by machining or formingdiametrically opposed flats 24, 26 on the body portion 14, the flatsbeing generally parallel. As best seen in FIG. 3, flats 24 are formed ondiametrically opposite sides of the barb portion 20 while the flats 26are formed on the diametrically opposite sides of the barb portion 22.

[0066] The device of FIGS. 1-3 and other similar devices disclosedherein may be fabricated by compacting comminuted or shredded naturallyoccurring ECM material into bar or rod stock by curing the material suchthat it is very rigid and hardened. The curing may be accomplished byair drying comminuted ECM at room temperature for several days.Comminuted ECM, when dried at room temperature for several days, becomesvery tough and hard and can be machined using conventional tools. In oneexample, a sample of 3 cc of comminuted SIS that has been air dried atroom temperature for several days produced a piece of SIS stock that is7-8 mm in diameter and 2 mm thick, and has a hardness of about 70 HRD onthe “Rockwell D” scale. For comparison, polyethylene tests at about 30HRD, and plexiglass is between 70 and 75 HRD on the “Rockwell D” scale(ASTM D2240, Vol. 0991). Testing was done using an e2000 seriesdurometer from PTC Instruments (model 502D). This durometer conforms tothe ASTM D2240 type D standard. The indentor in this type (as in alldurometers conforming to ASTM D2240 type D) is a sharp point indentorwith a 30 degree included angle and applies a force of 4536 gmf on thesample being tested.

[0067] Thus, in an illustrated embodiment an orthopaedic device isformed from comminuted SIS that has been air dried at room temperaturefor several days. The SIS has a hardness of at least 30 HRD on the “D”scale, particularly at least 50 on the “D” scale, more particularlyabove 60 HRD on the “D” scale, and most particularly about 70 HRD orabove on the “D” scale. A hardness of 60-70 is usable in manyapplications.

[0068] One sample of comminuted and air-dried SIS was found to have adensity of 0.747+/−0.059 gm/cc. For comparison, the density of thecommercially available RESTORE® product, an ECM laminate, is0.466+/−0.074 gm/cc. And, an ECM product consisting of toughened SISlaminate as described in “Meniscus Regeneration Device and Method”(provisional U.S. Patent Application No. 60/305,786 filed on Jul. 16,2001, and U.S. Patent Application Serial No. ______ entitled “MeniscusRegeneration Device and Method” (Attorney Docket No. 265280-71141,DEP-745), filed concurrently herewith, has been made with a density of0.933+/−0.061 gm/cc; and an SIS foam can be made as described in U.S.Patent Application Serial No. ______ entitled “Cartilage Repair andRegeneration Device and Method” (Attorney Docket No. 265280-71145,DEP-752), filed concurrently herewith and hereby incorporated byreference, with a substantially lower density: 0.091+/−0.019 gm/cm³;0.035+/−0.012 gm/cm³; or 0.006+/−0.002 gm/cm³, for example.

[0069] Drying and hardening may be accelerated by using heat and/orpressure. In an illustrated embodiment, the ECM may be comminuted usinga COMITROL machine from Urschel Laboratories (Valparaiso, Ind.), with aVericut sealed impeller at 9391 rpm.

[0070] Once the bar stock or rod stock is provided, it may be machinedwith conventional machine shop equipment to the desired shapes. Forexample, the device 10 may be turned on a lathe or similar equipment toproduce the head portion 12 and the body portion 14 with its generallyconical barb portions 20, 22. Then, illustratively, the flats 24, 26 maybe separately machined such that the conical portions 20, 22 will becomemore barb-like. It will be appreciated that various barb configurationsmay be formed on the device 10, for example, by cutting longitudinallyextending slots in the body portion 14 to provide more radiallyoutwardly barbs inclined axially toward the head portion 12.

[0071] It has been found that tacks or tack-like devices may be made asshown in FIGS. 1-3 such that they can be driven into bone tissue to besecurely anchored in the tissue. The head portion 12 of such devices 10may trap soft tissue against the bone surface. It will be appreciatedthat the head portion 12 may have a larger diameter than proportionatelyshown in FIGS. 1-3 and that the head portion 12 may have a shape otherthan the circular shape depicted in FIGS. 1-3. The head portion 12itself may be provided with a roughened or barbed surface facing end 16to attach to the soft tissue being anchored. It will be appreciated thata plurality of devices 10 may be used to secure soft tissue to bone.

[0072]FIG. 4 shows a device 30, similar to the device 10 of FIGS. 1-3except that the device 30 is longer. Throughout this description, somecorresponding portions of various devices will be identified with thesame reference numerals. For example, the device 30 in FIG. 4 has a headportion 12, a body portion 14, and a pointed distal end 16. The device30 has three barb portions and three sets of flats. The device 30, ofcourse, is to be driven further into the bone structure than the device10.

[0073]FIG. 5 shows a device 36 which is essentially a double-ended tack,each end of which is similar to the device 10 with a common head portion12, having an illustrative proportionately larger diameter than the headportion 12 of FIGS. 1-3. The device 36 of FIG. 5 is provided so that oneof its body portions 14 may be inserted into one bone or tissuestructure while the other body portion 14 may be inserted into anotherbone or tissue structure. The diameter of the head portion 12 of thedevice 36 may be made smaller or larger depending on the attachmentapplication.

[0074]FIG. 6 shows a device 40 which is a double-ended device similar todevice 36 of FIG. 5 except that one body portion 42 is threaded.Illustratively, the device 40 has another body portion 14 similar to thebody portion 14 of FIGS. 1-3, with a threaded opposite end portion 42.The head portion 44 of the device 40 may be hexagonal as illustrated orotherwise formed to provide a drive portion for inserting the device. Itwill be appreciated that a surgeon will be provided with a tubularsocket to receive and drivingly engage the head portion 44. Theillustrative device 40, which may be cannulated as indicated at brokenlines 46 so that the device 40 may be accurately positioned on a K-wire,may optionally have its threaded end provided with diametrically opposedflats 48 (FIG. 7). These flats 48 serve to impede rotation subsequent toimplantation.

[0075] One use of the device 40 shown in FIGS. 6 and 7 will be discussedin conjunction with inserting bone plugs in connection with FIGS. 17 and18.

[0076]FIG. 8 shows a tack 60 with a head portion 62 and an elongatedbody portion 64 having a distal end 66 that is somewhat sharpened to apoint. The tack 60 in FIG. 8 is provided with a pair of longitudinallyspaced apart, circumferential ridges 68 between the distal end 66 andthe head portion 62. These circumferential ridges 68 serve to lock thedevice into the surrounding native tissue (i.e. bone).

[0077] A device 70 shown in FIG. 10 is similar to devices 10 and 30except that the proximal body portion 72 including the head 74 is formedwith a central bore or opening 76 which may be filled with a mass ofcomminuted naturally occurring ECM. This central bore space 76 in thedevice 70 is therefore filled with a biological material to provide aframework for more rapid resorption.

[0078] A device 80 is shown in FIGS. 11 and 12 to have a head portion82, a body portion 84 with a distal sharpened end 85. It will beappreciated that the device 80 is similar to the prior devices exceptthat body portion 84 is formed to have three angularly spaced rows ofbarbs 86 formed at least in part by three angularly spaced apart,longitudinally extending grooves 88 best seen in FIG. 12. It will beappreciated that the barbs 86 are formed to extend radially outwardlyfrom the body portion 84 and inclined axially toward the head portion82. These barbs 86 and the barbs 20, 22 in the above-described devices10, 30, 36, 40 and 70 illustratively have an abrupt or sharp edge facingthe head portions of the device. It will be appreciated that when thedevices are inserted into a bone, the bone will close in on the bodyportions and these abrupt axially outwardly facing edges of the barbs tosecure the devices in the bone. The head portion 82 is shown havingthree angularly spaced notches 90, which are provided to aid in graspingin delivery of the device. Other configurations are within the scope ofthis invention.

[0079] In accordance with the present invention, a tack or tack-likedevice may be provided as shown in FIG. 9 without a head portion. FIG. 9illustrates a device 96, which may be cannulated as indicated at brokenlines 98, for insertion in the bone to hold soft tissue. As with devices10, 14, and 70, device 96 is provided with a plurality of barbs 92, 93,94. The device as shown in FIG. 9 illustratively may be used, forexample, as an interference screw for wedging a bone plug into a bonetunnel, such as for fixing a replacement ligament into the bone tunnel.

[0080] The designs shown in FIGS. 1-9, therefore, provide an orthopaedictack or barbed tack fabricated from naturally occurring ECM that hasbeen cured to be hard and rigid. These devices 10, 30, 36, 40, 60,70,80, and 96 may be fabricated from SIS which is cured to be hard andrigid by comminuting the SIS and allowing the comminuted SIS to air dry.

[0081] A device 110 is provided for attaching a soft tissue such as aligament or a tendon to a bone is shown in FIGS. 13-15, the device beingformed from a hardened mass of naturally occurring ECM to have anelongated body to be received in an opening formed in the bone. Thedevice 110 has a head portion 112, a central body portion 114 and adistal end 116 all shaped and configured for insertion into a boneopening having a diameter smaller than the largest diameter of thecentral body portion 114. The device 110 is also provided with acentral, longitudinal extending channel 118 extending axially throughthe device. The illustrative device 110 is further formed with axiallyand radially extending cut-out or slot 120 which opens from the channel118 to the exterior of the device 110. It will be appreciated that apiece of soft tissue which may be a ligament, a tendon, or a ligamentgraft such as an ACL graft, may be inserted axially into the channel 118to be carried with the device 110 into the bone. While the device 110 isformed from a hardened mass of naturally occurring ECM, it is configuredfor being forced into an opening prepared in a bone, and to collapseinwardly to grip the soft tissue 122 in the channel 118. The interior ofthe channel 118 may be provided with a roughened texture or eveninterior barbs or gripping surfaces to grip the soft tissue 122 moresecurely as the device 110 collapses radially inwardly. Central bodyportion 114 is provided with three radially outwardly extendingfrustcoconical engagers 124 which serve to anchor the device 110 in thebone. These engagers 124 have outer surfaces which incline axiallytoward the head portion 112 and radially outwardly. As the device 110 isdriven into the bone opening, these engagers 124 will cause the deviceto collapse inwardly by bringing the longitudinal walls of the cut-out120 closer together, reducing the diameter of the channel 118, andholding soft tissue 122 securely within bone 128, as shown in FIG. 14.The engagers 124, as illustrated in FIG. 13, have abrupt radiallyoutwardly extending and axially facing surfaces for anchoring the device110 in the bone opening.

[0082] It will be appreciated that the device 130 may be formed as athreaded device as shown in FIGS. 15-16 with helical thread segmentsreplacing the engagers 144 on the central body portion 134. When thedevice 130 is so threaded, and the head end portion 132 with thehex-shaped cuts 146 is engaged with a socket driver, with the driver endpreferably formed on a tube for receiving the soft tissue graft 142, thedevice 130 can be threaded into a bone opening.

[0083]FIGS. 17 and 18 show diagrammatically how the device 40 of FIGS. 6and 7 can be used to anchor a bone plug 150 into an opening 152 drilledor otherwise formed in a bone. The threaded body portion 42 of thedevice 40 may be threaded into a central opening in the bone plug 150 asdepicted in FIGS. 17 and 18. The opening 152 in the bone may be providedat a diameter which will snugly receive the bone plug 150. The barbedportion (body portion 14) of device 40 is provided to anchor into thebottom of the opening 152. It may be advantageous to provide a centralpilot hole 154 in the bottom of the opening 152 to receive and guide thebody portion 14 of the device 40. When the bone plug 150 is forced intothe opening 152, the structure shown in FIG. 18 will result with thedevice 40 anchoring the bone plug 150 in the bone.

[0084] It is contemplated that the method and device in FIGS. 17 and 18may be used to anchor a cartilage plug 156 into a bone. Essentially, adefect in the cartilage in the surface of a bone, such as on the condyleof a knee, will be removed by forming the opening 152 for receiving thebone plug 150. A cartilage graft 156 will be secured to the bone plug150 to be used to close the opening 158 made in the cartilage layer 160in the bone. Thus, the bone plug 150 and the anchoring device 140 may beused to hold a cartilage plug 156 in position in an opening 158 incartilage 160 such that cartilage plug 156 lies in an essentiallycontiguous plane with the undamaged surrounding cartilage 168.

[0085]FIGS. 19 and 20 show how a bone plug 170, which is illustrativelyformed as a cylindrical bone plug to be anchored into a cylindricalopening 172 in a bone, may be used with the device 36 shown in FIG. 5.The bone opening 172 is provided with a depth sufficient to receive aplug 170, and the bottom 175 of the opening 172 is provided with a pilothole 174. The plug 170 is prepared with a split end as indicated at 176and a central pilot opening 178 at bottom surface 179, for facing bottom175 of opening 172. It will be appreciated that this split end 176 ofthe bone plug 170 will be wedged outwardly by the device 36 so that theouter surface of the bone plug 170 will firmly engage the internalcylindrical surface of the bone opening 172. FIG. 20 shows the device 36with one of its end portions 14 anchored into the bone in the bottom ofthe opening 172.

[0086]FIGS. 21 and 22 show devices 180, 190 for use in anchoring boneplugs in openings formed in bones. The devices 180, 190 may be formedfrom naturally occurring extracellular matrix cured to be rigid andhardened. The device 180 is elongated on a central axis indicated at 182and may be cannulated on the axis as indicated at 184. Thus, the device180 may be slid onto a K-wire and located accurately between the outerwall of a bone plug and the inner wall of an opening in which the boneplug is to be anchored. The illustrative device 180 has a generallytriangular cross-section providing three longitudinally extendingsharpened edges 183 for cutting into the exterior of the bone plug andthe interior of the bone opening. Thus, the device 180 may be forcedinto the space between the exterior of the bone plug and the wall of theopening to extend along the bone plug and wedge the bone plug into firmengagement with the bone opening. The device 190, which is formed aboutthe axis 192 and which may also be cannulated as indicated at 194, isformed to be have a generally square cross-section providing fourlongitudinally extending side edges 193 to cut into the exterior of thebone plug and the interior of the bone opening.

[0087] In orthopedic surgery work, there are various reasons to insert abone plug into an opening formed in a bone. While circular bone plugsand circular bone openings are illustrated and discussed herein, it willbe appreciated that bone plugs may take various cross-sectional shapesdetermined by the instruments used to cut the plugs and the particularsurgical need. Typically, it is more convenient to drill a cylindricalopening into a bone for receiving a bone plug. To have the bone pluganchored and secured to the wall of the bone opening, it is oftennecessary to force the bone plug against the wall of the opening in thehost bone so that the required bone nourishment and eventual boneingrowth may take place. This aspect of anchoring bone plugs to boneopenings is well known in the orthopedic field. For example, in ACLsurgery, it is known to anchor a bone plug harvested on the end of apatellar tendon strip in a tunnel formed upwardly into the femur.Essentially, the patellar tendon is harvested with a bone plug on oneend of the strip. The other end may be provided with a bone plug aswell. This patellar strip is then used as an ACL graft replacement. Atunnel is formed upwardly through a tibial platform into the femur andthe ACL graft is secured in place by anchoring one of the bone plugs inthe femur and the other of the bone plugs in the tibia. Conventionally,cannulated screws are threaded into the openings to extend alongside thebone plugs. These screws thread into the bone plugs and into the wallsof the tunnels to push the plugs into engagement with the tunnel walls.The devices 180, 190 are provided as alternatives to the threadedscrews. These devices are pushed into the space between the exterior ofa wall of the bone plug and the interior wall of the bone opening. Sucha configuration is shown in FIG. 23 where the bone plug 200 isillustrated inserted into the opening or tunnel 202. Again, while theplug 200 is illustrated as having a cylindrical cross-section, it willbe appreciated that the plug 200 will have a cross-sectional shapedefined by the cutting tools used to remove the plug 200 from itsoriginal position. The device 190, however, will be inserted into thespace between the plug 200 and the wall of the opening 202 to force theplug against the wall of the opening. It is understood that FIG. 23shows only a portion of a ACL graft attached to the plug 200.

[0088] Referring to FIGS. 24 and 25, it will be seen that a bone plug210 may be secured in a tunnel 212 by barbed anchors 214. Each of thesebarbed anchors 214 may be formed from hardened naturally occurring ECMto have sharp barbs 216, 218 with a connector portion 220 having a rightangle extension 220 to be received into an opening 222 in the bone plug210. Thus, the barbed anchors 214 may be attached to the bone plug 210to extend along side the bone plug as it is inserted into the tunnel212. An ACL graft may be attached to the bone plug 210 as indicated at224.

[0089] The devices are made from ECM that has been cured to a hardnessto allow machining. Each of these devices retains its structuralintegrity for a sufficient period of time to allow the intendedorthopaedic fixation, and to permit bone or cartilage ingrowth or repairto begin. Preferably, the devices such as devices 180, 190 and anchors214 in FIGS. 23-25 as well as the devices 10, 30, 36, 40, 60, 70, 80,96, and 110 are designed to be absorbed into the host tissue, bone, orsoft tissue into which they are placed.

[0090] Referring to FIG. 26, it will be seen that an orthopedic device240 for attaching or repairing tissue is illustrated, the device 240comprising two spaced apart barb portions 242, 244, each of which has aproximal end portion 246, a sharpened distal end portion 248, and atleast one barb 243. The device 240 has a connecting member 250 extendingbetween the proximal ends 246 to provide a staple-like device. Each ofthe barb portions 242, 244 may be formed as previously discussed fromhardened and rigid naturally occurring ECM. The entire device 240 may bemachined from a single block of hardened ECM. Alternatively, barbportions 242, 244 and connecting member 250 may be machined separately,and the connecting member 250 may have its ends inserted into and joinedinto the proximal end portions 246 of the barb portions as indicated at252. Connecting member 250 may be affixed to the barb portions 242, 244in any number of ways, including threading or gluing at insertion 252.The device 240, therefore, may be used as a staple, for example, withthe barb portions 242, 244 inserted into the bone and the connectingmember 250 holding tissue to the bone. The connecting member 250 may beformed from hardened naturally occurring ECM, flexible ECM, or anothermaterial.

[0091]FIG. 27 shows a device 260 with similar spaced apart barb portions242, 244 and a connecting member 262 which is hollow and filled withcomminuted SIS.

[0092]FIG. 28 shows an approach for making a staple or staple-likedevice 270 having spaced apart barb portions 272, 274 and a connectingmember 276. The device 270 contemplates that a plurality of layers ofnaturally occurring ECM material will be laminated together to be curedby air drying to form a rigid and hardened plate-like body. Then, alaser machine unit 278 will be programmed to cut a pattern which willproduce a device 270 from the laminated layers of ECM. It has been foundthat such laser cutting of several layers of ECM will produce barbportions 272, 274 having cut edges which are sealed and fused togetherto enhance the attachment capability of the barbs 273. Device 270 mayoptionally have a plurality of laser cut holes 275, which further fusetogether the layers of ECM.

[0093]FIGS. 31 and 32 show devices 280 and 290, respectively, withdifferent patterns cut from such laminated layers of rigid and hardenednaturally occurring ECM. The device 280 is shown having three spacedapart barb portions 282, 284, 286 with a bowed or curved connectingmember 288 extending between the proximal ends of the barb portions. Thedevice 290 in FIG. 32 is shown as having three spaced apart barbportions 292, 294 and 296 with a member 298 connecting the proximal endsof the barbs. Illustratively, the barb portions 282, 284, 286 and theconnecting member 288 may all lie in a common plane. Alternatively, theconnecting member 288 may be warped or curved so that the barb portions282, 284, 286 do not necessarily lie in a common plane. In the device290, the barb portions 292, 294, 296 initially start out being paralleland lying in a common plane. It will be appreciated that the connectingmember 298 may be manipulated by the surgeon to relocate the directionof the barb portions 292, 294, 296.

[0094]FIG. 29 shows the staple-like device 310 comprising a pair ofspaced apart barb portions 312, 314 formed as discussed above. Thesebarb portions 312, 314 are connected by a connecting member 316extending between the proximal ends of the barb portions. The device 310comprises strips of naturally occurring ECM laminated together to form abody portion 320 to be placed down into a tear in a cartilaginoussurface such as a meniscus. The barbs 313 hold the body 320 in the tear.It is contemplated that the ends of the body 320 will be attachedsecurely to the barb portions 312, 314. One method of attaching body 320to barb portions 312, 314 is to insert edges of the body 320 into slotsprovided in body portions 312, 314. Illustratively, the barbs may beprovided with a slit for receiving and gripping and holding the ends ofthe body 320. It is contemplated that, once the device 310 is fullyinserted in the meniscus tear and attached with the barb portions 312,314, the connecting member 316 and the upper ends of the barb portionsmay be cut away leaving a structure such as that shown in FIG. 29(a).The body portion 320 may have characteristics different from those ofthe barb portions 312, 314. For example, the body portion 320 may have agreater porosity or lower density or lower hardness than the barbportions, and may have characteristics similar to those of commercialproducts like the RESTORE patch, for example. It should be understoodthat these possible differences in characteristics are provided by wayof example only; the illustrated embodiments are not intended to limitthe material for the body portion 320.

[0095]FIG. 30 shows a device 340 comprising a body such as the body 320made from laminating layers of naturally occurring ECM together. Theends of the body 320 in the device 340 are attached to the connectingmembers 250 similar to two devices 240 or 260 as shown in FIGS. 26 and27.

[0096] It is anticipated that the hardened ECM devices of the presentinvention can be combined with one or more bioactive agents (in additionto those already present in naturally occurring ECM), one or morebiologically-derived agents or substances, one or more cell types, oneor more biological lubricants, one or more biocompatible inorganicmaterials, one or more biocompatible synthetic polymers and one or morebiopolymers. Moreover, the hardened ECM devices of the present inventioncan be combined with devices containing such materials.

[0097] “Bioactive agents” include one or more of the following:chemotactic agents; therapeutic agents (e.g. antibiotics, steroidal andnon-steroidal analgesics and anti-inflammatories, anti-rejection agentssuch as immunosuppressants and anticancer drugs); various proteins (e.g.short chain peptides, bone morphogenic proteins, glycoprotein andlipoprotein); cell attachment mediators; biologically active ligands;integrin binding sequence; ligands; various growth and/ordifferentiation agents (e.g. epidermal growth factor, IGF-I, IGF-II,TGF-β I-III, growth and differentiation factors, vascular endothelialgrowth factors, fibroblast growth factors, platelet derived growthfactors, insulin derived growth factor and transforming growth factors,parathyroid hormone, parathyroid hormone related peptide, bFGF; TGF_(β)superfamily factors; BMP-2; BMP-4; BMP-6; BMP-12; sonic hedgehog; GDF5;GDF6; GDF8; PDGF); small molecules that affect the upregulation ofspecific growth factors; tenascin-C; hyaluronic acid; chondroitinsulfate; fibronectin; decorin; thromboelastin; thrombin-derivedpeptides; heparin-binding domains; heparin; heparan sulfate; DNAfragments and DNA plasmids. If other such substances have therapeuticvalue in the orthopaedic field, it is anticipated that at least some ofthese substances will have use in the present invention, and suchsubstances should be included in the meaning of “bioactive agent” and“bioactive agents” unless expressly limited otherwise.

[0098] “Biologically derived agents” include one or more of thefollowing: bone (autograft, allograft, and xenograft) and derivates ofbone; cartilage (autograft, allograft, and xenograft), including, forexample, meniscal tissue, and derivatives; ligament (autograft,allograft, and xenograft) and derivatives; derivatives of intestinaltissue (autograft, allograft, and xenograft), including for examplesubmucosa; derivatives of stomach tissue (autograft, allograft, andxenograft), including for example submucosa; derivatives of bladdertissue (autograft, allograft, and xenograft), including for examplesubmucosa; derivatives of alimentary tissue (autograft, allograft, andxenograft), including for example submucosa; derivatives of respiratorytissue (autograft, allograft, and xenograft), including for examplesubmucosa; derivatives of genital tissue (autograft, allograft, andxenograft), including for example submucosa; derivatives of liver tissue(autograft, allograft, and xenograft), including for example liverbasement membrane; derivatives of skin tissue; platelet rich plasma(PRP), platelet poor plasma, bone marrow aspirate, demineralized bonematrix, insulin derived growth factor, whole blood, fibrin and bloodclot. Purified ECM and other collagen sources are also intended to beincluded within “biologically derived agents.” If other such substanceshave therapeutic value in the orthopaedic field, it is anticipated thatat least some of these substances will have use in the presentinvention, and such substances should be included in the meaning of“biologically-derived agent” and “biologically-derived agents” unlessexpressly limited otherwise.

[0099] “Biologically derived agents” also include bioremodelablecollageneous tissue matrices. The expressions “bioremodelablecollagenous tissue matrix” and “naturally occurring bioremodelablecollageneous tissue matrix” include matrices derived from native tissueselected from the group consisting of skin, artery, vein, pericardium,heart valve, dura mater, ligament, bone, cartilage, bladder, liver,stomach, fascia and intestine, tendon, whatever the source. Although“naturally occurring bioremodelable collageneous tissue matrix” isintended to refer to matrix material that has been cleaned, processed,sterilized, and optionally crosslinked, it is not within the definitionof a naturally occurring bioremodelable collageneous tissue matrix topurify the natural fibers and reform a matrix material from purifiednatural fibers. The term “bioremodelable collageneous tissue matrices”includes “extracellular matrices” within its definition.

[0100] “Cells” include one or more of the following: chondrocytes;fibrochondrocytes; osteocytes; osteoblasts; osteoclasts; synoviocytes;bone marrow cells; mesenchymal cells; stromal cells; stem cells;embryonic stem cells; precursor cells derived from adipose tissue;peripheral blood progenitor cells; stem cells isolated from adulttissue; genetically transformed cells; a combination of chondrocytes andother cells; a combination of osteocytes and other cells; a combinationof synoviocytes and other cells; a combination of bone marrow cells andother cells; a combination of mesenchymal cells and other cells; acombination of stromal cells and other cells; a combination of stemcells and other cells; a combination of embryonic stem cells and othercells; a combination of precursor cells isolated from adult tissue andother cells; a combination of peripheral blood progenitor cells andother cells; a combination of stem cells isolated from adult tissue andother cells; and a combination of genetically transformed cells andother cells. If other cells are found to have therapeutic value in theorthopaedic field, it is anticipated that at least some of these cellswill have use in the present invention, and such cells should beincluded within the meaning of “cell” and “cells” unless expresslylimited otherwise. Illustratively, in one example of embodiments thatare to be seeded with living cells such as chondrocytes, a sterilizedimplant may be subsequently seeded with living cells and packaged in anappropriate medium for the cell type used. For example, a cell culturemedium comprising Dulbecco's Modified Eagles Medium (DMEM) can be usedwith standard additives such as non-essential amino acids, glucose,ascorbic acid, sodium pyrovate, fungicides, antibiotics, etc., inconcentrations deemed appropriate for cell type, shipping conditions,etc.

[0101] “Biological lubricants” include: hyaluronic acid and its salts,such as sodium hyaluronate; glycosaminoglycans such as dermatan sulfate,heparan sulfate, chondroiton sulfate and keratan sulfate; synovial fluidand components of synovial fluid, including mucinous glycoproteins (e.g.lubricin), tribonectins, articular cartilage superficial zone proteins,surface-active phospholipids, lubricating glycoproteins I, II;vitronectin; and rooster comb hyaluronate. “Biological lubricant” isalso intended to include commercial products such as ARTHREASE™ highmolecular weight sodium hyaluronate, available in Europe from DePuyInternational, Ltd. of Leeds, England, and manufactured byBio-Technology General (Israel) Ltd., of Rehovot, Israel; SYNVISC® HylanG-F 20, manufactured by Biomatrix, Inc., of Ridgefield, N.J. anddistributed by Wyeth-Ayerst Pharmaceuticals of Philadelphia, Pa.;HYLAGAN® sodium hyaluronate, available from Sanofi-Synthelabo, Inc., ofNew York, N.Y., manufactured by FIDIA S.p.A., of Padua, Italy; andHEALON® sodium hyaluronate, available from Pharmacia Corporation ofPeapack, New Jersey in concentrations of 1%, 1.4% and 2.3% (forophthalmologic uses). If other such substances have therapeutic value inthe orthopaedic field, it is anticipated that at least some of thesesubstances will have use in the present invention, and such substancesshould be included in the meaning of “biological lubricant” and“biological lubricants” unless expressly limited otherwise.

[0102] “Biocompatible polymers” is intended to include both syntheticpolymers and biopolymers (e.g. collagen). Examples of biocompatiblepolymers include: polyesters of [alpha]-hydroxycarboxylic acids, such aspoly(L-lactide) (PLLA) and polyglycolide (PGA); poly-p-dioxanone (PDS);polycaprolactone (PCL); polyvinyl alcohol (PVA); polyethylene oxide(PEO); polymers disclosed in U.S. Pat. Nos. 6,333,029 and 6,355,699; andany other bioresorbable and biocompatible polymer, co-polymer or mixtureof polymers or co-polymers that are utilized in the construction ofprosthetic implants. In addition, as new biocompatible, bioresorbablematerials are developed, it is expected that at least some of them willbe useful materials from which the anchors may be made. It should beunderstood that the above materials are identified by way of exampleonly, and the present invention is not limited to any particularmaterial unless expressly called for in the claims.

[0103] “Biocompatible inorganic materials” include materials such ashydroxyapatite, all calcium phosphates, alpha-tricalcium phosphate,beta-tricalcium phosphate, calcium carbonate, barium carbonate, calciumsulfate, barium sulfate, polymorphs of calcium phosphate, sintered andnon-sintered ceramic particles, and combinations of such materials. Ifother such substances have therapeutic value in the orthopaedic field,it is anticipated that at least some of these substances will have usein the present invention, and such substances should be included in themeaning of “biocompatible inorganic material” and “biocompatibleinorganic materials” unless expressly limited otherwise.

[0104] It is expected that various combinations of bioactive agents,biologically derived agents, cells, biological lubricants, biocompatibleinorganic materials, biocompatible polymers can be used with thehardened ECM devices of the present invention.

[0105] It is expected that standard disinfection (e.g. 0.15% peraceticacid in 20% ethanol) and sterilization techniques (e.g. electron beam orgamma irradiation) may be used with the products of the presentinvention. Although it is anticipated that some of the identifiedadditives could be added to the devices prior to terminal sterilization,other additives, such as cells, for example, would be cultured onpreviously sterilized devices. In addition, some bioactive agents couldbe added to the devices in the operating room, such as an autograft ofPRP for example.

[0106] The hardened ECM devices of the present invention can also becombined with other devices that include naturally occurring ECM, and itis expected that the hardened ECM devices can be combined with purifiedECM and commercially available collagen materials and/or with devicesthat contain purified ECM and commercially available collagen materials.

[0107] Illustrative applications for the hardened ECM devices of thepresent invention, and potential materials to be incorporated with thehardened ECM devices of the present invention, are illustrated in thefollowing U.S. Patent Applications, filed concurrently herewith andincorporated by reference herein in their entireties: Serial No. ______entitled “Meniscus Regeneration Device and Method” (Attorney Docket No.265280-71141, DEP-745); Serial No. ______ entitled “Cartilage RepairApparatus and Method” (Attorney Docket No. 265280-71143, DEP-749);Serial No. ______ entitled “Unitary Surgical Device and Method”(Attorney Docket No. DEP-750); Serial No. ______ entitled “HybridBiologic/Synthetic Porous Extracellular Matrix Scaffolds” (AttorneyDocket No. 265280-71144, DEP-751); Serial No. ______ entitled “CartilageRepair and Regeneration Device and Method” (Attorney Docket No.265280-71145, DEP-752); and Serial No. ______ entitled “Cartilage Repairand Regeneration Device and Method” (Attorney Docket No. 265280-71145,DEP-752). Thus, implants can be made as composites of materials ofdifferent characteristics.

[0108] Although the invention has been described in detail withreference to certain preferred embodiments, variations and modificationsexist within the scope and spirit of the invention as described anddefined in the following claims.

1. An orthopedic device for attaching soft tissue such as cartilage, ligament and tendons to bone, the device having a head portion configured to engage soft tissue and a body portion configured to engage and attach to the bone, the head portion and body portion being monolithic and formed from naturally occurring extracellular matrix (ECM) cured to be rigid and hardened to facilitate attachment to the bone.
 2. The device of claim 1 in which the body portion terminates with a pointed end distal from the head portion to facilitate penetration into the bone.
 3. The device of claim 2 in which the body portion between the pointed end and the head portion is formed with radially outwardly extending barbs.
 4. The device of claim 3 in which the barbs are inclined toward the head portion.
 5. The device of claim 4 in which the body portion is provided with diametrically opposed flats extending therealong, the flats being generally parallel.
 6. The device of claim 5 in which the device is formed by machining a mass of the cured matrix to define the head portion and body portion.
 7. The device of claim 1 in which the cured ECM is cured by air drying.
 8. The device of claim 1 in which the cured ECM is dried at room temperature.
 9. The device of claim 1 in which the cured ECM is dried with pressure.
 10. The device of claim 1 in which the cured ECM is dried with heat.
 11. The device of claim 10 in which the cured ECM is dried with pressure.
 12. The device of claim 1 in which the cured ECM has a hardness of at least 30 on the “D” scale.
 13. The device of claim 1 in which the cured ECM has a hardness of at least 60 on the “D” scale.
 14. The device of claim 1 in which the cured ECM has a hardness of at least 70 on the “D” scale.
 15. The device of claim 1 in which the body portion is formed with an outer shell defining a central core space, and comprising a biological material to provide a framework for tissue regeneration disposed in the space.
 16. The device of claim 15 in which the biological material is comminuted naturally occurring ECM.
 17. The device of claim 16 in which the cured ECM is SIS and the comminuted ECM is SIS.
 18. The device of claim 1 in which the head portion and body portion are formed about a central axis and concentrically and axially cannulated to receive a guide member.
 19. The device of claim 1 in which the head portion and body portion are formed about a central longitudinal axis and a second body portion is provided to extend axially away from the head portion in a direction opposite to the first mentioned body portion.
 20. The device of claim 19 in which the second body portion is threaded.
 21. The device of claim 20 in which the second body portion is provided with diametrically opposed, longitudinally extending generally parallel flats in the portion threaded.
 22. The device of claim 21 in which the first mentioned body portion is provided with outwardly extending barbs.
 23. The device of claim 22 in which the barbs extend radially outwardly and axially toward the head portion.
 24. The device of claim 23 in which the first mentioned body portion terminates with a pointed end distal from the head portion.
 25. A device for repairing a tear in a cartilaginous surface such as a meniscus, the device comprising strips of naturally occurring extracellular matrix laminated together to form a body portion to be placed down into the tear to extend along the tear, and one or more tacks coupled to the body portion to secure it in the tear, each of the one or more tacks being formed from naturally occurring extracellular matrix cured to be hard and rigid.
 26. The device of claim 25 in which the body portion has an upper edge, a lower edge and opposite end edges, the one or more tacks comprising a tack coupled to each of the opposite end edges of the body portion.
 27. The device of claim 26 in which each tack extends along the opposite end edge to which it is coupled.
 28. The device of claim 27 in which the body portion is coupled to each tack along its length.
 29. The device of claim 28 in which each tack is provided with barbs which extend radially outwardly and axially toward the upper edge.
 30. The device of claim 25 comprising a member connecting the one or more tacks, the connecting member being formed from naturally occurring extracellular matrix.
 31. The device of claim 30 in which the connecting member is detachable by a surgeon after the body portion and tacks are inserted into the tear.
 32. The device of claim 25 in which the ECM is SIS.
 33. The device of claim 32 in which the SIS is dried at room temperature.
 34. The device of claim 32 in which the SIS has a hardness of at least 30 on the “D” scale.
 35. The device of claim 32 in which the SIS has a hardness of at least 60 on the “D” scale.
 36. The device of claim 32 in which the SIS has a hardness of at least 70 on the “D” scale.
 37. The device of claim 25 in which the one or more tacks comprise a pair of tacks each having a pointed distal end and a proximal end and a connecting member coupled between the proximal ends of the tacks, the connecting member being coupled to the body portion.
 38. The device of claim 37 in which the connecting member extends transverse to the body portion, the connecting member having a central portion coupled to the body portion.
 39. An orthopedic device for attaching or repairing tissue, the device comprising two spaced apart barbs, each barb having a sharpened distal end and a proximal end, and a member connecting the proximal ends of the barbs, the barbs being formed from naturally occurring extracellular matrix.
 40. The device of claim 39 in which the connecting member is formed of the naturally occurring extracellular matrix.
 41. The device of claim 40 in which the matrix is SIS.
 42. The device of claim 39 in which the connecting member and the barbs are formed from layers of naturally occurring extracellular matrix laminated together and cured to form a rigid and hardened sheet-like body, the barbs and the connecting member being cut from the body.
 43. The device of claim 42 in which the barbs and connecting member are cut by laser machining a pattern on the sheet-like body.
 44. The device of claim 43 in which the barbs have edges formed by fusing the layers together in the laser machining.
 45. The device of claim 44 further having a plurality of laser-cut holes.
 46. The device of claim 42 comprising a third barb cut from the sheet-like body and having a sharpened distal end and a proximal end formed from the sheet-like body, the connecting member being cut from the sheet-like body to connect to the proximal end of the third barb.
 47. The device of claim 46 in which the three barbs lie in generally the same plane.
 48. The device of claim 39 in which the barbs and the connecting member are machined from a single piece of extracellular matrix.
 49. The device of claim 39 in which the barbs are machined from extracellular matrix cured to be hard and rigid and each barb has a proximal end portion configured to receive an end of the connecting member.
 50. The device of claim 49 in which the connecting member is machined from extracellular matrix.
 51. A device for anchoring a bone plug in an opening formed in a bone, the device comprising a mass of naturally occurring extracellular matrix formed into a rigid and hardened member configured to be wedged in the opening between the bone plug and the bone.
 52. The device of claim 51 in which the member has a body portion formed with outwardly extending barbs to dig into the bone plug and bone.
 53. The device of claim 52 in which the member is provided with a connecting portion to extend into the bone plug.
 54. The device claim 51 in which the member is elongated to extend axially along side the bone plug, the member having a plurality of radially outwardly and longitudinally extending fins to dig into the bone plug and bone.
 55. The device of claim 54 in which the elongated member is cannulated longitudinally to be sleeved over an elongated guide member such as a K-wire.
 56. The device of claim 51 in which the matrix is SIS.
 57. The device of claim 56 in which the SIS is cured by drying at room temperature to form the rigid and hardened member.
 58. The device of claim 56 in which the SIS has a hardness of about 70 on the “D” scale.
 59. The device of claim 51 in which the member is formed in the shape of a screw to be threaded into the opening between the bone plug and bone.
 60. A method for anchoring a bone plug into an opening formed in a bone for receiving the plug, the method comprising the steps of: (a) providing a member formed into a rigid and hardened mass of naturally occurring extracellular matrix, and (b) placing the member into the opening between the bone plug and the bone.
 61. The method of claim 60 in which the member is elongated to extend alongside the bone plug to be wedged between the bone plug and bone.
 62. The method of claim 60 in which the member is elongated and threaded to provide a screw to be threaded between the bone plug and the bone.
 63. The method of claim 60 in which the bone opening is formed with cylindrical wall and a bottom to receive a cylindrical bone plug, and the placing step comprising placing the member in the opening to engage the bone plug and the bone.
 64. The method of claim 63 in the member is provided as a double-ended tack, one end of which extends into the bottom of the opening and the other end of which extends into a bottom surface of the bone plug.
 65. The method of claim 64 in which the bottom surface of the bone plug is formed to have a split end, and the placing step further comprises forcing the bone plug split end over the other end of the tack to wedge the bone plug outwardly against the bone opening wall.
 66. The method of claim 65 in which the split end of the bone plug is provided with a central pilot hole for receiving the other end of the tack.
 67. The method of claim 60 in which the matrix is SIS.
 68. The method of claim 67 in which the SIS is cured by drying at room temperature to form the rigid and hardened member.
 69. The method of claim 68 in which the SIS has a hardness of about 70 on the “D” scale.
 70. The method of claim 60 in which the member is provided with barbs that dig into the bone plug and the bone.
 71. A device for attaching a soft tissue to a bone that has been prepared with an opening to receive the device, the device being formed from a hardened mass of naturally occurring extracellular matrix to form an elongated body to be received in the opening, the body having a channel therein for receiving a portion of the soft tissue, the body being configured to collapse inwardly to grip and hold the soft tissue portion in the channel when the body is inserted into the opening.
 72. The device of claim 71 in which the body is elongated and formed generally about an axis, the body having a threaded outer surface to accomplish threading the device into the bone opening.
 73. The device of claim 72 in which the body is formed such that the channel is a central bore extending through at least a portion of the body, the body having an axially extending slot opening between the channel and the outer surface to accommodate the inward collapse of the device as the device is threaded into the bone opening.
 74. The device of claim 71 in which the matrix is SIS.
 75. The device of claim 74 in which the mass of SIS is dried to be hardened and then machined to have external threads for threadedly engaging the bone opening.
 76. The device of claim 75 in which the device is provided with an axial slot to accommodate the inward collapse of the device as it is threaded into the bone opening.
 77. The device of claim 71 in which the body is elongated and formed generally about an axis, the body having an outer surface providing radially outwardly extending engagers to engage into bone.
 78. The device of claim 71 in which the engagers are formed to have axially and radially inclined surfaces that force the device to collapse inwardly.
 79. An orthopedic device comprising a mass of naturally occurring extracellular matrix having a hardness greater than 30 HRD on the Rockwell D Scale.
 80. The orthopedic device of claim 79 wherein the mass of naturally occurring extracellular matrix has a hardness of at least 50 HRD on the Rockwell D scale.
 81. The orthopedic device of claim 79 wherein the mass of naturally occurring extracellular matrix has a hardness of at least 60 HRD on the Rockwell D scale.
 82. The orthopedic device of claim 79 wherein the mass of naturally occurring extracellular matrix has a density greater than 0.5 g/cc.
 83. The orthopedic device of claim 79 wherein the mass of naturally occurring extracellular matrix has a density greater than 0.7 g/cc.
 84. The orthopedic device of claim 79 wherein the device comprises a composite with a material selected from the group consisting of: a bioactive agent; a biologically derived agent; a biological lubricant; a biocompatible polymer; a biocompatible inorganic material; cells; chondrocytes; osteocytes; synoviocytes; a naturally occurring ECM that has a hardness less than 70 HRD on the Rockwell D Scale; a naturally occurring ECM having a density less than 0.7 g/cc; a mat including a nonwoven naturally occurring ECM; braided naturally occurring ECM; an ECM foam; an ECM laminate; an ECM woven; a biologically absorbable polymer laminate; a biologically absorbable polymer foam; a biologically absorbable polymer woven material; and a mat including a nonwoven naturally occurring biologically absorbable polymer.
 85. The orthopedic device of claim 79 wherein the device comprises a configuration selected from the group consisting: an orthopedic tack comprising a monolithic head portion and a body portion; an anchor for attaching soft tissue to bone, the device having a portion configured to engage soft tissue and an integral portion configured to engage bone; an anchor comprising at least two spaced apart barbs, each barb having a sharpened distal end and a proximal end, the device further comprising a member connecting the proximal ends of the barbs; an anchor comprising at least two spaced apart barbs and an integral member connecting the two barbs; an anchor for anchoring a bone plug in an opening formed in bone, the naturally occurring extracellular matrix being configured to be wedged between the bone plug and the bone; an anchor comprising a body having a channel therein, the body being configured to collapse inwardly under compression; and a outer shell portion and an inner portion surrounded by the shell, wherein the outer shell portion has a hardness greater than 30 HRD on the Rockwell D Scale and the inner portion has a hardness less than 50 HRD on the Rockwell D Scale.
 86. The orthopedic device of claim 85 wherein the device is a composite with a material selected from the group consisting of: a bioactive agent; a biologically derived agent; a biological lubricant; a biocompatible polymer; a biocompatible inorganic material; cells; chondrocytes; osteocytes; synoviocytes; a naturally occurring extracellular matrix that has a hardness less than 70 HRD on the Rockwell D Scale; a naturally occurring extracellular matrix having a density less than 0.7 g/cc; a mat of nonwoven naturally occurring extracellular matrix; an ECM foam; an ECM laminate; an ECM woven; a biologically absorbable polymer laminate; a biologically absorbable polymer foam; a biologically absorbable polymer woven; and a mat of nonwoven naturally occurring biologically absorbable polymer.
 87. The orthopedic device of claim 86 wherein the mass of naturally occurring extracellular matrix has a hardness of at least 60 HRD on the Rockwell D Scale.
 88. The orthopedic device of claim 86 wherein the mass of naturally occurring extracellular matrix has a hardness of at least 70 HRD on the Rockwell D scale.
 89. A composite orthopedic device comprising two connected portions, each portion comprising naturally occurring extracellular matrix material, each portion having a hardness and a density, wherein one portion is configured for anchoring the device to native tissue and has a hardness of not less than 30 HRD on the Rockwell D Scale and a density greater than 0.5 g/cc, and the other portion has a different configuration, a different hardness and a different density.
 90. The composite orthopedic device of claim 89 wherein at least one of the portions has a density of not less than 0.7 g/cc.
 91. The composite device of claim 89 wherein at least one of the portions comprises a material selected from the group consisting of: a bioactive agent; a biologically derived agent; a biological lubricant; a biocompatible polymer; a biocompatible inorganic material; cells; chondrocytes; osteocytes; synoviocytes; a mat including nonwoven naturally occurring extracellular matrix; an ECM foam; an ECM laminate; an ECM woven; a toughened ECM material; a biologically absorbable polymer laminate; a biologically absorbable polymer foam; a biologically absorbable polymer woven; and a mat including nonwoven naturally occurring biologically absorbable polymer.
 92. The composite device of claim 89 wherein the device comprises a configuration selected from the group consisting of: an orthopedic tack comprising a monolithic head portion and a body portion; an anchor for attaching soft tissue to bone, the device having a portion configured to engage soft tissue and an integral portion configured to engage bone; an anchor comprising at least two spaced apart barbs, each barb having a sharpened distal end and a proximal end, the device further comprising a member connecting the proximal ends of the barbs; an anchor comprising at least two spaced apart barbs and an integral member connecting the two barbs; an anchor for anchoring a bone plug in an opening formed in bone, at least part of the device being configured to be wedged between the bone plug and the bone; an anchor comprising a body having a channel therein, the body being configured to collapse inwardly under compression; a meniscal repair device comprising a pair of barbs and a sheet of naturally occurring extracellular matrix material extending between the barbs; an outer shell portion and an inner portion surrounded by the shell, wherein the outer shell portion has a density greater than the inner portion; and a wedge-shaped body having an upper panel and a lower panel angularly separated to define an apex portion and a base portion, the panels being formed of a naturally-occurring extracellular matrix.
 93. An orthopedic device comprising bioremodelable collageneous tissue matrix having a hardness greater than 30 HRD on the Rockwell D Scale.
 94. The orthopedic device of claim 93 wherein the bioremodelable collageneous tissue matrix has a hardness of at least 60 HRD on the Rockwell D scale.
 95. The orthopedic device of claim 93 wherein the bioremodelable collageneous tissue matrix has a hardness of at least 70 HRD on the Rockwell D scale.
 96. The orthopedic device of claim 93 wherein the bioremodelable collageneous tissue matrix has a density greater than 0.5 g/cc.
 97. The orthopedic device of claim 96 wherein the bioremodelable collageneous tissue matrix has a density greater than 0.7 g/cc.
 98. The orthopedic device of claim 93 wherein the device further comprises a material selected from the group consisting of: a bioactive agent; a biologically derived agent; a biological lubricant; a biocompatible polymer; a biocompatible inorganic material; cells; chondrocytes; osteocytes; synoviocytes; a naturally occurring bioremodelable collageneous tissue matrix that has a hardness less than 70 HRD on the Rockwell D Scale; a naturally occurring bioremodelable collageneous tissue matrix having a density less than 0.7 g/cc; a mat including a nonwoven naturally occurring bioremodelable collageneous tissue matrix; braided naturally occurring bioremodelable collageneous tissue matrix; a foam comprising bioremodelable collageneous tissue matrix; a laminate comprising bioremodelable collageneous tissue matrix; a woven material comprising bioremodelable collageneous tissue matrix; a biologically absorbable polymer laminate; a biologically absorbable polymer foam; a biologically absorbable polymer woven material; and a mat including a nonwoven biologically absorbable polymer.
 99. The orthopedic device of claim 93 wherein the device comprises a configuration selected from the group consisting of: an orthopedic tack comprising a monolithic head portion and a body portion; an anchor for attaching soft tissue to bone, the device having a portion configured to engage soft tissue and an integral portion configured to engage bone; an anchor comprising at least two spaced apart barbs, each barb having a sharpened distal end and a proximal end, the device further comprising a member connecting the proximal ends of the barbs; an anchor comprising at least two spaced apart barbs and an integral member connecting the two barbs; an anchor for anchoring a bone plug in an opening formed in bone, the bioremodelable collageneous tissue matrix being configured to be wedged between the bone plug and the bone; an anchor comprising a body having a channel therein, the body being configured to collapse inwardly under compression; and a outer shell portion and an inner portion surrounded by the shell, wherein the outer shell portion has a hardness greater than 50 HRD on the Rockwell D Scale and the inner portion has a hardness less than 70 HRD on the Rockwell D Scale.
 100. The orthopedic device of claim 99 wherein the device is a composite with a material selected from the group consisting of: a bioactive agent; a biologically derived agent; a biological lubricant; a biocompatible polymer; a biocompatible inorganic material; cells; chondrocytes; osteocytes; synoviocytes; a naturally occurring bioremodelable collageneous tissue matrix that has a hardness less than 70 HRD on the Rockwell D Scale; a naturally occurring bioremodelable collageneous tissue matrix having a density less than 0.7 g/cc; a mat of nonwoven naturally occurring bioremodelable collageneous tissue matrix; a foam comprising bioremodelable collageneous tissue matrix; a laminate comprising bioremodelable collageneous tissue matrix; a woven material comprising bioremodelable collageneous tissue matrix; a biologically absorbable polymer laminate; a biologically absorbable polymer foam; a biologically absorbable polymer woven; and a mat of nonwoven biologically absorbable polymer.
 101. The orthopedic device of claim 100 wherein the bioremodelable collageneous tissue matrix has a hardness of at least 60 HRD on the Rockwell D Scale.
 102. The orthopedic device of claim 100 wherein the bioremodelable collageneous tissue matrix has a hardness of at least 70 HRD on the Rockwell D scale.
 103. A composite orthopedic device comprising two connected portions, each portion comprising naturally occurring bioremodelable collageneous tissue matrix, each portion having a hardness and a density, wherein one portion has a hardness of no less than 30 HRD on the Rockwell D Scale and a density greater than 0.5 g/cc, and the other portion has a different hardness and a different density.
 104. The composite orthopedic device of claim 103 wherein at least one of the portions has a density of not less than 0.7 g/cc.
 105. The composite device of claim 103 wherein at least one of the portions comprises a material selected from the group consisting of: a bioactive agent; a biologically derived agent; a biological lubricant; a biocompatible polymer; a biocompatible inorganic material; cells; chondrocytes; osteocytes; synoviocytes; a mat including nonwoven naturally occurring bioremodelable collageneous tissue matrix; a foam comprising bioremodelable collageneous tissue matrix; a laminate comprising bioremodelable collageneous tissue matrix; a woven material comprising bioremodelable collageneous tissue matrix; a toughened bioremodelable collageneous tissue matrix material; a biologically absorbable polymer laminate; a biologically absorbable polymer foam; a biologically absorbable polymer woven; and a mat including nonwoven biologically absorbable polymer.
 106. The composite device of claim 103 wherein the device comprises a configuration selected from the group consisting of: an orthopedic tack comprising a monolithic head portion and a body portion; an anchor for attaching soft tissue to bone, the device having a portion configured to engage soft tissue and an integral portion configured to engage bone; an anchor comprising at least two spaced apart barbs, each barb having a sharpened distal end and a proximal end, the device further comprising a member connecting the proximal ends of the barbs; an anchor comprising at least two spaced apart barbs and an integral member connecting the two barbs; an anchor for anchoring a bone plug in an opening formed in bone, at least part of the device being configured to be wedged between the bone plug and the bone; an anchor comprising a body having a channel therein, the body being configured to collapse inwardly under compression; a meniscal repair device comprising a pair of barbs and a sheet of naturally occurring extracellular matrix material extending between the barbs; and an outer shell portion and an inner portion surrounded by the shell, wherein the outer shell portion has a density greater than the inner portion. 